Safety Physician

CTC; Basel; On-site; CHF 140,000 - 190,000; Full time

Job summary

CTC in Basel is seeking a highly experienced MD with a strong background in clinical research and early-phase trials. You will oversee medical monitoring, pharmacovigilance, and causality assessments, ensuring safety data quality and regulatory compliance across multi-centre studies.

Ideal candidates have extensive GCP/GLP knowledge, CRO/CDO collaboration experience, and a track record in autoimmune/IBD settings.

Qualifications

• MD or equivalent medical degree required.
• Extensive clinical research or development experience in pharma/biotech, preferably early trials.
• Strong knowledge of clinical trial methodology and regulatory requirements.
• Good Clinical Practices (GCP) and GLP knowledge.
• Experience working with CROs/CDOs in multi-centre trials.
• Prior exposure to autoimmune diseases/IBD is a plus.

Responsibilities

• Oversee medical monitoring and pharmacovigilance activities.
• Provide causality assessments and safety reviews of data.
• Review coding activities (MedDRA) and safety analyses.
• Lead safety review for case processing and aggregate reporting.
• Contribute to study design, conduct and reporting of early trials (Ph1/2).
• Develop medical review documents (protocols, amendments, safety plans).
• Collaborate with Clinical Operations and Biomarker teams to meet milestones.
• Ensure data generation and analysis align with GCP/SOPs and timelines.

Skills

MD

Clinical research

Early clinical trials

GCP/GLP knowledge

Regulatory/compliance

Team leadership

CRO/CfD collaboration

Swiss/EU permit

Autoimmune/IBD experience

Education

MD or equivalent medical degree

Job description

Main Responsibilities:

• Perform medical monitoring and pharmacovigilance activities (such as medical oversight of the study, eligibility checks, review safety data)
• Provide causality assessments
• Review of coding activities (MedDRA…)
• Perform safety review of clinical and diagnostic data as part of case processing and aggregate reporting
• Provide medical review of aggregate reports (DSUR…)
• Assist with generation of project specific procedures (medical review activities)
• Contribute to design, execution/conduct and report of Ph1/2 clinical trials in I&I space
• Contribute to medical team and clinical development strategy
• Ensure that safety and efficacy data is generated and analyzed according to GCP/SOPs, corporate strategy and timelines
• Work closely with cross-functional team members to ensure planning and execution of clinical trials to meet key study milestones
• Contribute to the development of statistical analysis plan, and in the review, interpretation, and communication of clinical trial data from clinical trials
• (Co)-Author and develop clinical documents like, clinical study protocols and amendments and review other clinical documents like safety management plan, medical monitoring plan
• Work closely with colleagues from Clinical Operations and Clinical Biomarker department to deliver clinical study program goals and milestones

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• You have an advanced medical degree (MD)
• You have several years of clinical research or clinical development experience in pharmaceutical/biotechnological industry, ideally in early clinical trials
• You have strong knowledge of clinical trial methodology, regulatory and compliance requirements of clinical trials
• You have knowledge of Good Clinical Practices / Good laboratory Practices and clinical study design
• You are a talented, pro-active and passionate medical professional, inspired by our shared vision to bring innovation to patients with unmet medical needs
• You understand the framework and complexities of early clinical multi-centre trials and can deal with various CRO/CDO-related ways of working
• You have ideally experience in the autoimmune disease and/or IBD (I&I) space
• You thrive leading or being an active member of large or small diverse teams